Crosser Enters The Right Arterial Lumen (CENTRAL)

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The purpose of this study is to determine if the CROSSER CTO Recanalization System can facilitate the successful crossing of Chronic Total Occlusions in the Central lumen of the Superficial Femoral Artery (SFA). A Chronic Total Occlusion (CTO) is defined as 100% narrowing of the artery, with no angiographically detectable antegrade blood flow, and the assessment that the lesion has been in existence for a minimum of 30 days. This study will enroll up to 100 patients at up to 8 clinical sites. The CROSSER CTO Recanalization System was cleared for commercialization by the US Food & Drug Administration. This study also involves an imaging device called the IVUS (Intravascular Ultrasound Imaging) catheter. This device has been cleared for commercialization by the US Food and Drug Administration and will be studied for its cleared intended use. The IVUS catheter is used to generate real-time images of the artery, which will allow for evaluation of the artery after the occlusion is crossed. This is a post-market registry.

Detailed Description

Not Provided

Study Type

Observational

Study Design

Observational Model: Case-OnlyTime Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Patients with CTO who are indicated for recanalization.

Condition

Chronic Total Occlusion of Artery of the Extremities

Intervention

Device: 1. CROSSER System

The Crosser system will be used to recanalize the chronic total occlusion in the SFA (superficial femoral artery). The IVUS (Intravascular Ultrasound Imaging) System will be used in the treated occlusion after the Crosser to generate real-time images of the artery.

Other Names:

Crosser catheter

IVUS catheter

Study Groups/Cohorts

CROSSER

Intervention: Device: 1. CROSSER System

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status

Completed

Enrollment

100

Completion Date

August 2012

Primary Completion Date

August 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

Patient must have objective evidence of lower extremity ischemia and scheduled to undergo an endovascular recanalization.

Occluded artery must be the native superficial femoral artery.

Patient must have a totally occlusive lesion classified angiographically as absolute (100% occlusion with no flow).

Patient's target vessel occlusion length is ≤ 30 cm.

Patient's reference vessel diameter is greater than or equal to 3.0mm.

Patient has other medical illnesses (i.e., cancer or congestive heart failure) that may cause the patient to be non-compliant with the protocol, confound the data interpretation or is associated with life-expectancy less than 1 year.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

No

Contacts

Contact information is only displayed when the study is recruiting subjects